Tocilizumab, a drug that was recommended by the Indian Council for Medical Research ( ICMR) for emergency use in coronavirus ( COVID-19 ) patients, has been found to be ineffective in reducing the associated pneumonia, according to a press release issued by its promoters.
Though unproven, a rise in cases and mortality translated into a global scamper for the drug. There was high demand for it in India too with stocks running out at pharmacists and reports that it was being blackmarketed for as much as ₹1.5 lakh a dose.
Originally developed for rheumatoid arthritis, Actemra/RoActerma, the brand name under which the drug is sold, was first approved by the United States’ Food and Drug Administration to be tested in large phase-3 trial randomised, double-blinded control trial called COVACTA in March.
The primary aim was to check if the drug, which is given intravenously, improved health or reduced mortality when compared to standard of care treatment. About 450, with severe COVID-19-related pneumonia, were a part of the trial.
There was no difference between Actemra/RoActemra and placebo in the percentage of patients that died by week four. For those who were discharged from hospital, those who didn’t get the drug on average were likely to spend 28 days in hospital whereas those on the drug spent 20—the latter the only positive that was highlighted by the company. Taking the drug also didn’t improve patients’ chances of staying off ventilator support or even reducing their dependence on it, say the results.
“People around the world are waiting for further effective treatment options for COVID-19 and we are disappointed that COVACTA did not demonstrate a benefit for patients in either clinical status or mortality at week four. We will continue to generate evidence to provide a more complete understanding of Actemra/RoActemra in COVID-19 associated pneumonia,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development, in a statement.
Tocilizumab works by suppressing the action of interleukin 6, a pro-inflammatory chemical that the immune system relies on to recruit a host of cells that can destroy the Sars-Cov-2 virus. However an excess of this commandeering can damage healthy cells and even kill the patient. Medical researchers have been trying drugs, such as tocilizumab, to modulate the immune system.
A drug with similar action is Biocon's itolizumab that has been approved by Drug Controller General of India for emergency use but has been marked out as having unproven in saving lives by the ICMR.